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FDA 510(k)

Ambu Duodeno System

K-Number: K201098 · 2020-07-17

ApplicantAmbu Innovation GmbH
Decision Date2020-07-17
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ambu Duodeno System is a medical device manufactured by Ambu Innovation GmbH. It received FDA 510(k) clearance on 2020-07-17 under approval number K201098. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu Duodeno System?

Ambu Duodeno System is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Ambu Innovation GmbH. The 510(k) number is K201098.

When was Ambu Duodeno System approved by the FDA?

Ambu Duodeno System received FDA 510(k) clearance on 2020-07-17, under approval number K201098.

What company makes Ambu Duodeno System?

Ambu Duodeno System is manufactured by Ambu Innovation GmbH.

What is the FDA product code for Ambu Duodeno System?

The FDA product code for Ambu Duodeno System is FDT.

Related Clinical Trials

NCT06467955 MagDI Canada Study ACTIVE_NOT_RECRUITING NCT06473831 MagDI Australia Study ACTIVE_NOT_RECRUITING NCT06613711 MagDI Italian Study COMPLETED NCT07317115 Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes RECRUITING

Related Devices (Code: FDT)

K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp. K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. K182051FUJIFILM Duodenoscope ModelFujifilm Corporation K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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